OCULAR RESPONSE ANALYZER
Tonometer, Ac-powered
REICHERT INC.
The following data is part of a premarket notification filed by Reichert Inc. with the FDA for Ocular Response Analyzer.
Pre-market Notification Details
| Device ID | K081756 |
| 510k Number | K081756 |
| Device Name: | OCULAR RESPONSE ANALYZER |
| Classification | Tonometer, Ac-powered |
| Applicant | REICHERT INC. 3362 WALDEN AVE. Depew, NY 14043 |
| Contact | Sandra Brown |
| Correspondent | Sandra Brown REICHERT INC. 3362 WALDEN AVE. Depew, NY 14043 |
| Product Code | HKX |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-20 |
| Decision Date | 2008-08-07 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812559011020 | K081756 | 000 |
Trademark Results [OCULAR RESPONSE ANALYZER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OCULAR RESPONSE ANALYZER 77112519 3545476 Live/Registered |
Reichert, Inc. 2007-02-21 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.